24.02.2016
To the attention of interested persons
Related to NAMMD notification of 27 January 2016, on technical requirements for NAMMD acceptance (validation of submission) of electronic application forms for authorisation, renewal, variations (electronic Application Form, eAF) as of 01.03.2016, i.e.:
1. “active PDF” format;
2. Integrated XML;
3. Blocked by the applicant upon change/save, please consider the following:
– The Electronic Application Form (eAF) has to be included in the eCTD format and not submitted separately (such as by e-mail);
– An activated copy (saved prior to blocking) will be made available to applicants for inclusion of amendments required by the NAMMD upon validation of submission;
– Applicants can also use the electronic signature when signing applications in electronic format (eAF);
– Applicants’ technical questions may be submitted directly to the eAF Maintenance Group. Please be reminded of the following:
– Electronic forms and technical documentation are available at: http://esubmission.ema.europa.eu/eaf/index.html
– For full details, please see the eAF webpage, “Guidance documents”.